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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05854901
Other study ID # NL72662.078.20
Secondary ID NL9122
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2021
Est. completion date February 2025

Study information

Verified date May 2023
Source Erasmus Medical Center
Contact Michael L van Schaik, MD/MSc
Phone +31615283010
Email m.l.vanschaik@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study the investigators will examine whether procalcitonin-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.


Description:

Chronic obstructive pulmonary disease (COPD) is a prevalent disease, worldwide, and in the Netherlands with approximately 600.000 patients. COPD is currently the 3rd leading cause of death worldwide and is also a leading cause of disability-adjusted life years. Given the contribution of exacerbations both to loss in quality of life and to health-care costs, it is of paramount importance to improve the current treatment of exacerbations. Pulmonary physicians are well aware of overuse of antibiotics, but lack the tools to decide which medication to give in the clinical setting. Biomarkers may aid towards a more personalized treatment of acute COPD exacerbations (AECOPD). Procalcitonin (PCT), the precursor of calcitonin, is released in response to a bacterial infection by many tissues within 6-12 hours after the onset of infection, while the concentration is only minimally raised in viral infections, making it a relative specific diagnostic tool for bacterial infection. Several trials have shown a reduction in antibiotic consumption in AECOPD when using a PCT-guided treatment algorithm. Recent systematic reviews concluded that appropriately powered trials are lacking to confirm that clinical outcomes are comparable with usual care. In this study the investigators will examine whether a PCT-guided treatment regarding antibiotic therapy is non-inferior to usual care in patients who are admitted because of an acute COPD exacerbation when it comes to treatment failure on day 30.


Recruitment information / eligibility

Status Recruiting
Enrollment 693
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - COPD, according to GOLD 2018 definition - Indication for hospitalization because of acute severe exacerbation of COPD, as defined by GOLD 2018 and modified Anthonisen criteria - Presence of at least 2 major symptoms of the modified Anthonisen criteria (acute deterioration in sputum volume, sputum purulence and dyspnea) or the presence of 1 major symptom and 1 minor symptom (coughing, wheeze, nasal discharge, sore throat, fever) - Post-bronchodilator FEV1/FVC < 0,70 and FEV1% < 80%pred. within last 5 years - At least 40 years - Smokers or ex-smokers with > 10 packyears - Written informed consent - Start of symptoms no more than 7 days before admission Exclusion Criteria: - Indication for ICU and or non-invasive ventilation < 72h of admission - Pneumonia, radiologically confirmed - Infection at another site and/or sepsis according to the SIRS criteria (with tachycardia and tachypnea not being caused by the exacerbation) - COPD before age 40 - Asthma, without presence of COPD. - Patients with COPD , with or without a history of asthma (in childhood or as an adolescent) will NOT be excluded/are allowed to participate. - Patients with Asthma/COPD overlap syndrome (with current asthma AND COPD) will NOT be excluded/are allowed to participate. - Clinically relevant heart failure or myocardial ischemia - Chronic use of immunosuppressants, including prednisolone (a prednisone equivalent of 10mg or less is allowed/is NOT an exclusion criterion) - Known bronchiectasis as a primary diagnosis - Colonisation with Pseudomonas spp. or other micro-organisms in recent cultures (last 60 days) not susceptible to amoxicillin-clavulanic acid - Pregnancy - Recent exacerbation (last 28 days)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Procalcitonin
blood test, measuring the concentration of PCT in ug/L
Other:
Physician's decision
The physician's decided whether the patient will receive antibiotic treatment or not

Locations

Country Name City State
Netherlands Noordwest hospital group Alkmaar Noord-Holland
Netherlands OLVG Amsterdam Noord-Holland
Netherlands Amphia hospital Breda Noord-Brabant
Netherlands Catharina hospital Eindhoven Noord-Brabant
Netherlands MST Enschede Enschede Overijssel
Netherlands Groene Hart Gouda Zuid-Holland
Netherlands Zuyderland hospital Heerlen Limburg
Netherlands Bravis hospital Roosendaal Noord-Brabant
Netherlands Erasmus MC Rotterdam Zuid-Holland
Netherlands Franciscus Gasthuis & Vlietland Rotterdam Zuid-Holland
Netherlands Isala klinieken Zwolle Overijssel

Sponsors (2)

Lead Sponsor Collaborator
Erasmus Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost-effective analysis Alongside the clinical trial, an economic evaluation will be performed conform the guidelines of the Health Care Institute Netherlands (17). This evaluation will be conducted from a societal and payer's perspective. When adopting the societal perspective, costs will include 30-day inpatient and outpatient (emergency room, specialist visits) hospital costs, primary care costs (visits to GP and nurse practitioner), medication costs, ambulance costs, productivity costs, informal care costs and travel costs. 30 days
Primary Treatment failure Treatment failure is defined as disease-related mortality, need for endotracheal intubation or vasopressors, renal failure (defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 - new renal replacement therapy, tripling of baseline creatinine, or serum creatinine > or = 350 umol/L), lung abcess/empyema, development of pneumonia or rehospitalization within 30 days after inclusion. 30 days
Secondary Incomplete resolution of the clinical signs and symptoms Incomplete resolution of the clinical signs and symptoms associated with the AECOPD at day 30 after inclusion of the study (i.e. not reaching the baseline condition prior to the AECOPD) scored using the modified Anthonisen criteria change between baseline and after 30 days
Secondary Incomplete resolution of the clinical signs and symptoms Incomplete resolution of the clinical signs and symptoms associated with the AECOPD at day 30 after inclusion of the study (i.e. not reaching the baseline condition prior to the AECOPD) scored using the modified Anthonisen criteria day 30
Secondary Modified Anthonisen criteria Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure baseline
Secondary Modified Anthonisen criteria Patients fill in the modified Anthonisen criteria card on day 3 day 3
Secondary Modified Anthonisen criteria Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure day 5
Secondary Modified Anthonisen criteria Patients fill in the modified Anthonisen criteria card on day 1 as a baseline measure day 10
Secondary Decision to start antibiotic therapy after an initial opposite decision (after 48 hours) Decision to start antibiotic therapy after an initial opposite decision (after 48 hours) 30 days
Secondary Side effects of antibiotic treatment Side effects of antibiotic treatment, such as gastro-intestinal complaints, allergic reactions 30 days
Secondary Cumulative antibiotic consumption The cumulative amount of antibiotic treatment consumed by the patient during follow-up 30 days
Secondary Cumulative prednisolone consumption The cumulative amount of prednisolone consumed by the patient during follow-up 30 days
Secondary Length of hospitalization Duration of time (in days) of the admission in hospital for the index exacerbation during follow-up up to 30 days
Secondary Re-exacerbation The presence of a new exacerbation, requiring treatment (prednisolone and/or antibiotic treatment) during follow-up 30 days
Secondary EXACT respiratory questionnaire PROM symptom score: EXACT - Respiratory symptoms scale change between baseline and after 30 days
Secondary EXACT respiratory questionnaire PROM symptom score: EXACT - Respiratory symptoms scale baseline
Secondary EXACT respiratory questionnaire PROM symptom score: EXACT - Respiratory symptoms scale day 10
Secondary EXACT respiratory questionnaire PROM symptom score: EXACT - Respiratory symptoms scale day 30
Secondary CAT COPD assessment test, quality of life questionnaire baseline
Secondary CAT COPD assessment test, quality of life questionnaire day 10
Secondary CAT COPD assessment test, quality of life questionnaire day 30
Secondary CAT COPD assessment test, quality of life questionnaire change between baseline and day 30
Secondary EQ-5D-5L quality of life questionnaire baseline
Secondary EQ-5D-5L quality of life questionnaire day 10
Secondary EQ-5D-5L quality of life questionnaire day 30
Secondary EQ-5D-5L quality of life questionnaire change between baseline and day 30
Secondary iMCQ Medical consumption questionnaire, measuring the total amount of medical consumption (admission, ER visits, outpatient visits) during follow-up 30 days
Secondary Non-invasive ventilation after 72 hours of admission Need for non-invasive ventilation after 72 hours of admission 30 days
Secondary Time to complete resoluation of symptoms ยท Time to complete resolution of symptoms according to daily symptom diaries evaluating the modified Anthonisen criteria 30 days
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